The present invention pertains to diagnostic electrodes, which are utilized in electrocardiogram examinations.
In such an examination, a diagnostic electrode is electrically connected to the diagnostic equipment and affixed to the patient's body. It is important to not only properly position the electrode on the patient, but also, to do so without excessive handling. Any additional handling of the electrode increases the tendency that the integrity of the electrode may be disturbed, which would in turn, foul the results of the test.
Diagnostic electrodes, in contrast to more expensive monitoring electrodes which include a metal snap mounted to an adhesive coated foam, fabric or plastic web wherein an adhesive coated body adhering surface surrounds the conductive gel coated snap, typically comprise a thin, vinyl or paper backing layer, a tin foil layer and a sticky, conductive gel. The tin foil layer is the middle operative layer which connects the electrode with the equipment. The backing layer conforms to the shape of the tin foil layer and is bonded thereto, to increase the electrode's strength and durability, and to shield its operative portions from damage. The conductive gel is a sticky substance which is applied to the tin foil layer, on a surface opposite to the backing layer, and is used to affix the electrode to the patient. The entire tin foil surface, except for a small end tab, is coated with the gel. The tab is left uncoated to facilitate grasping by the user and attaching of a clip from the diagnostic equipment.
The electrodes are mounted in rows on a release web, which is a plastic or release paper sheet, for storage and dispensing, with their conductive gel layers pressed against the web. Such diagnostic electrodes do not adhere well to the patient and are difficult to use. Only a small amount of space on the electrode is left uncoated whereby the user may grip the electrode to remove it from the release web and attach the clip. To avoid excessive handling during the set up operation, the user may attach the clip to the electrode before removal from the web or after attachment to the patient. An attempt to attach the clip while holding the electrode is a procedure which is prone to error and fouling of the electrode because of the small size of the uncoated tab.
Some users try to attach the clip to the electrode, before the electrode is removed from the web. This is an operation which takes some care and therefore is not accomplished quickly or easily. The user must carefully separate the uncoated tab of the electrode from the release web in order to facilitate attachment of a clip. The user must then peel the electrode from the web, transfer it to the patient, and affix it to the patient's body in the proper position, without dislodging the clip. Due to the thin, somewhat slippery construction of the backing and tin foil layers, the user employing this procedure is faced with a formidable task. As a result, the clip is frequently dislodged during the set up procedure, which then requires the user to start over or attempt to reattach the clip after affixation of the electrode to the body.
Consequently, some users have adopted the procedure of attaching the clip to the electrode subsequent to affixation of the electrode to the body. In this way, the electrode can be more easily removed from the web and attached to the patient in its proper position. Yet, many difficulties face the user employing this procedure, regardless of whether the user intended to subsequently attach the clip or is faced with a reattachment procedure.
In a manner similar to attaching the clip before removal of the electrode from the web, the user must carefully separate the uncoated tab of the electrode from the patient's body, to attach the clip. Additionally, the user also runs the risk of upsetting the proper positioning of the electrode or knocking the electrode completely from the patient. This risk is particularly acute if the patient is sweaty, hairy, moves or is jarred while the user attempts to attach the clip. If this occurs, the user must then restart the test and begin the set up procedure anew.